How to Leverage Cockpit
Problems arise because organizations have a hard time managing the intersection of data, processes, and deliverables. All three areas of business must work together to produce a quality product; if one area fails, the whole system will fail. This intersection can be managed more easily with the Cockpit Platform.
All data used in the development process is collected from research and development, experiments, and lab data, otherwise known as batches. Cockpit’s REST API is designed to allow a user or team of users to select which data needs to be aggregated from those batches. Once all the work has been done, the output is an exportable document containing all the required information about the process and the drug being made.
Pharmaceutical and combination product developers and manufacturers live and breathe their Standard Operating Procedures (SOPs) and Work Instructions (WIs). These procedures and instructions drive the work of everyone in the organization. The Cockpit Platform’s unified model and centralized database make it perfect for housing these SOPs and WIs. Built-in workflow functions and other mechanisms allow for companies to insert their procedures and processes directly into the platform, making compliance with their processes easy. If SOPs change, the platform is ready to accept the changes to facilitate necessary modifications to procedures.
Once all the work is complete, batches aggregated, reviews and sign-offs done, it is time to create deliverables. Cockpit’s capabilities allow you to export your electronic deliverables to PDF, Word, Excel, or XML. These exported files can then be moved to storage in your company’s system of record.
Cockpit Platform Modules
Common Technical Document (CTD) Reporting is required for all BLA and IND submissions to FDA. Without a CTD process in place, your pharmaceutical or combination product’s time to market will be delayed.
Cockpit provides several optional base modules out of box to help your organization fulfill CTD Reporting requirements. These configurable modules provide a Dossier-centric approach to help streamline and focus your drug development activities.
Our base modules have three major focus areas:
Process Assessment – Identify hazards, harms, risks, etc. associated with your drug recipe requirements, specifications, and processes.
Criticality Analysis – Evaluate risk controls for your drug recipe and develop controlling requirements that feed back into the Recipe Portal.
Batch Analysis – Utilize analytical procedures to test batches of drug recipes and document results.
Comparability – Test proposed Chemistry, Manufacturing, and Control (CMC) changes on product quality with identified test acceptance criteria. Run comparative assessments of quality attributes before and after changes. Develop impurities profiles and stability studies.
Pharma Features in Cockpit
Pharma Features in Cockpit
Manage all risk-related activities in Cockpit. Custom scoring and color settings are available.
Cockpit’s built-in report and report creation abilities allow teams to gather information on anything.
Easily allocate design inputs, users neets, etc. to sub-systems of the design.
Built-In Risk Analysis
Evaluate using FMEA, FTA, pFMEA, dFMEA, and more. All included with the Cockpit Platform.
Manage all aspects of requirements and their connections within the platform.
Hold informal and formal reviews of anything within your project. Everything is stored centrally.